American Surgical Delicot 4 mm x 50 mm Ref Number: 63-05 Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
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Surgical Instruments
🏥 Medical Devices • 6,839 recalls
American Surgical Ultracot 30 mm x 70 mm (Glassine) Ref Number: 23-10G Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
American Surgical Uniqcot 1/2" x 3" Ref Number: 67-09 Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
American Surgical Tonsil Sponges 1" Large Ref Number: 50-01 Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
Mass Eye & Ear Finger Cot Nasal 2's Ref Number: 41-04 Product Usage: Neurosurgical and Nonneurosurgical Sponges
American Surgical Company
Class I - Dangerous
Product packaging defective compromising sterility
Class I - Dangerous
The product has potential to leak beyond their design specification.
Class I - Dangerous
The product has potential to leak beyond their design specification.
Potential for the Visualase Cooled Laser Applicator System (VCLAS) catheters to melt during procedures.
Class I - Dangerous
The product has potential to leak beyond their design specification.
Class I - Dangerous
The device may have a defect in the catheter. In some instances this defect could result in catheter separation or breakage.
Direct Drive Clip Applier CA090, indicated for ligation of tubular structures or vessels in laparoscopic and general surgical procedures. Distributed individually and in kits.
Applied Medical Resources
Class I - Dangerous
Increased customer complaints indicating inconsistent clip application; may lead to unoccluded vessels.
A component failure could cause a situation where the applied torque was significantly higher than the calibrated torque setting.
Launcher Guiding Catheter Model #LA6EBU30. Used in the coronary or peripheral vascular system..
Stryker Sustainability Solutions
Class I - Dangerous
Device packaging may not be sealed.
Class I - Dangerous
The recalling firm received complaints related to leakage from the tubing near the white luer of the irrigation line for the INFINITI Ultrasound Packs.
Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the Instructions For Use (IFU) and product labeling for this catheter relative to patients with prosthetic valves.
Biosense Webster is recalling the Pentaray Catheters to clarify the contraindication language in the Instructions For Use (IFU) and product labeling for this catheter relative to patients with prosthetic valves.
TLC¿ Self-Retaining Retractor Frames SINGLE USE ONLY Rx ONLY (USA) STERILE EO Do Not Resterilize. Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
Applied Medical Technology
Class I - Dangerous
The firm received a complaint of an open pouch which breaches the sterilization validation.
TLC¿ Self Retaining Retractor System Contents 1-RETRACTOR FRAME 6-ELASTIC STAYS STERILE EO Rx ONLY Product Usage: Indicated to aid in tissue retraction during a surgical procedure.
Applied Medical Technology
Class I - Dangerous
The firm received a complaint of an open pouch which breaches the sterilization validation.
ev3, PowerCross" 0.018" OTW PTA Dilatation Catheter, model: AB18W030200150, Sterile EO, Rx Only.
ev3
Class I - Dangerous
Medtronic is conducting a voluntary Urgent Medical Device Recall of two lots of the PowerCross 0.018" ¿ Over the Wire (OTW) Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter because the product is mislabeled.
Firm's quarterly dose audit testing showed that one batch was radiated below the augmented dose and therefore did not meet the augmented dose of 28.4 kGy.